Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
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| ClinicalTrials.gov Identifier: NCT04904276 |
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Recruitment Status :
Active, not recruiting
First Posted : May 27, 2021
Last Update Posted : August 30, 2022
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Sponsor:
Rigel Pharmaceuticals
Information provided by (Responsible Party):
Rigel Pharmaceuticals
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Brief Summary:
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).
| Condition or disease | Intervention/treatment |
|---|---|
| ITP Immune Thrombocytopenia | Drug: Fostamatinib |
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).
| Study Type : | Observational |
| Estimated Enrollment : | 45 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy (FORTE) |
| Actual Study Start Date : | May 18, 2021 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Fostamatinib
| Group/Cohort | Intervention/treatment |
|---|---|
| Initiating treatment with fostamatinib as second-line therapy |
Drug: Fostamatinib
Fostamatinib disodium |
| Treated with fostamatinib for at least 12 weeks as second-line therapy |
Drug: Fostamatinib
Fostamatinib disodium |
Primary Outcome Measures :
- Fostamatinib dosing [ Time Frame: 12-month observation period ]Changes in fostamatinib dosing
- Platelet counts over time during the course of fostamatinib therapy [ Time Frame: 12-month observation period ]Platelet count and change from baseline in platelet count over time.
- Use of concomitant medications related to ITP [ Time Frame: 12-month observation period ]Use of concomitant medications related to ITP during the study.
- Use of ITP Rescue Medication [ Time Frame: 12-month observation period ]The number of patients with ITP rescue medication use at any time during the study.
- Safety of fostamatinib [ Time Frame: 12-month observation period ]Evaluate continued safety of fostamatinib in ITP patients through adverse events
- ITP-PAQ Quality of life measure [ Time Frame: 12-month observation period ]Use of the score from questionnaire to assess disease-specific quality of life in adults with ITP.
- Treatment satisfaction measure (MSQ) [ Time Frame: 12-month observation period ]
- SF-36 Quality of life measure [ Time Frame: 12-month observation period ]Scale of functional health and well-being from the patient's point of view.
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
This two-cohort study will enroll approximately 45 patients diagnosed with ITP. Cohort 1 will enroll approximately 30 ITP patients who will begin treatment with fostamatinib as second-line therapy. Cohort 2 will enroll approximately 15 patients who have a record of at least 12 weeks of fostamatinib treatment as second-line therapy, with the intent to continue, at time of enrollment.
Criteria
Inclusion Criteria:
- Willing and able to provide written informed consent
- Diagnosis of ITP in adult patients (≥ 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy
- For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy
- For Cohort 2, currently undergoing treatment with fostamatinib as second line therapy for at least 12 weeks, with the intent to continue, at the time of enrollment
Exclusion Criteria:
- Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)
- Participation in any interventional study during the course of this study
- Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2
- Pregnant and/or nursing
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04904276
Locations
| United States, Florida | |
| Advanced Research | |
| Tamarac, Florida, United States, 33321 | |
| United States, Illinois | |
| Simmons Cancer Institute at Southern Illinois University | |
| Springfield, Illinois, United States, 62702 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Maryland | |
| Saint Agnes Hospital | |
| Baltimore, Maryland, United States, 21229 | |
| The Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| Maryland Oncology Hematology, P.A | |
| Clinton, Maryland, United States, 20735 | |
| Maryland Oncology Hematology, P.A | |
| Columbia, Maryland, United States, 21044 | |
| Maryland Oncology Hematology, P.A | |
| Rockville, Maryland, United States, 20850 | |
| Maryland Oncology Hematology, P.A | |
| Silver Spring, Maryland, United States, 20904 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Missouri | |
| Washington University | |
| Saint Louis, Missouri, United States, 63130 | |
| United States, New Jersey | |
| Regional Cancer Care Associates, LLC | |
| Little Silver, New Jersey, United States, 07739 | |
| United States, New York | |
| New York Medical College Westchester Medical Center | |
| Valhalla, New York, United States, 10532 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
Sponsors and Collaborators
Rigel Pharmaceuticals
| Responsible Party: | Rigel Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04904276 |
| Other Study ID Numbers: |
O-FOSTA-901 |
| First Posted: | May 27, 2021 Key Record Dates |
| Last Update Posted: | August 30, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Rigel Pharmaceuticals:
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Immune Thrombocytopenia ITP |
Additional relevant MeSH terms:
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Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders |
Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Hemorrhage Pathologic Processes Skin Manifestations |